HIV-1-infectionNCT03579381
Specimen Repository for HIV Immunopathogenesis
An observational study of HIV-1-infection and Acute HIV Infection, run by AIDS Healthcare Foundation at 1 site in United States.
Trial summary
Specimen Repository for HIV Immunopathogenesis Studies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection, Acute HIV Infection
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2017to 25 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Acutely HIV infected individuals HIV infected individuals who are not on anti-retrovirals and have a viral load between 50 and 3,000 HIV infected individuals who are not on anti-retrovirals and have a viral load less than 49
Who may be able to join
- HIV positive (acutely infected, viremic and elite controllers)
- Signed Informed Consent Form
- Age at least 18 years old
- Immune controllers, two types: "Elite suppressors" (HIV-positive with any three consecutive plasma HIV-1 RNA PCR undetectable while off treatment) or "viremic suppressors" (HIV-positive with any three consecutive HIV-1 RNA PCR <3000 while off treatment).
- Acutely infected subjects:
- Persons identified to have a negative HIV antibody response (ELISA) but positive detection of HIV-1 in the blood (RT-PCR) or individuals who have evidence of a recent (past 30 days) HIV negative result along with a current HIV positive result.
Who cannot join
- Uncontrolled bleeding diathesis.
- Pregnant.
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
AIDS Healthcare Foundation - Public Health Division
Los Angeles, California, 90027
About this study
Specimen Repository for HIV Immunopathogenesis Studies
Read the detailed description
The goal is to build a large specimen repository for collaborating scientists to run studies of immunity and HIV-1.
- Conditions
- HIV-1-infection, Acute HIV Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Immune Controllers | Patients with very low or undetectable levels of viremia without treatment | |
| Acute Infection | Early infection, i.e. within 2 weeks of infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV progression from acute infection to viral suppression
Outcomes will depend on scientists who use the samples for further study
Measured: 2 years
HIV progression and control by elite and viremic suppressors
Outcomes will depend on scientists who use the samples for study
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start31 Jul 2017
- Primary completion25 Jan 2019
- Study completion25 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIDS Healthcare Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Otto O Yang, MD, Study director, Scientific Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579381
- Sponsor's protocol ID
- AHF 03
- Status last verified
- Jan 2021
- First submitted
- 9 Jan 2018
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specimen Repository for HIV Immunopathogenesis
- ClinicalTrials.gov ID
- NCT03579381
- Acronym / sponsor ID
- AHF 03
- Conditions
- HIV-1-infection, Acute HIV Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- AIDS Healthcare FoundationUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 25 Jan 2019 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 6 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Specimen Repository for HIV Immunopathogenesis Studies
Detailed description
The goal is to build a large specimen repository for collaborating scientists to run studies of immunity and HIV-1.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immune Controllers | – | –Patients with very low or undetectable levels of viremia without treatment |
| Acute Infection | – | –Early infection, i.e. within 2 weeks of infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Acutely HIV infected individuals HIV infected individuals who are not on anti-retrovirals and have a viral load between 50 and 3,000 HIV infected individuals who are not on anti-retrovirals and have a viral load less than 49
Key inclusion criteria (6 listed)
- HIV positive (acutely infected, viremic and elite controllers)
- Signed Informed Consent Form
- Age at least 18 years old
- Immune controllers, two types: "Elite suppressors" (HIV-positive with any three consecutive plasma HIV-1 RNA PCR undetectable while off treatment) or "viremic suppressors" (HIV-positive with any three consecutive HIV-1 RNA PCR <3000 while off treatment).
- Acutely infected subjects:
Key exclusion criteria (3 listed)
- Uncontrolled bleeding diathesis.
- Pregnant.
- Inability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HIV progression from acute infection to viral suppression
Time frame: 2 years
Outcomes will depend on scientists who use the samples for further study
HIV progression and control by elite and viremic suppressors
Time frame: 2 years
Outcomes will depend on scientists who use the samples for study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Otto O Yang, MD study director
Scientific Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection and Acute HIV Infection, run by AIDS Healthcare Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV progression from acute infection to viral suppression (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.